Trividia Health recalled 12,067,458 TRUE METRIX blood glucose meters sold worldwide due to inadequate labeling. The manuals failed to emphasize that an E-5 error code could indicate a dangerously high blood glucose level. Users must stop using these devices immediately and contact their healthcare provider for further instructions.
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Trividia Health, Inc. or your healthcare provider for instructions. Notification method: Letter
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TRUE METRIX blood glucose meters are widely used by individuals monitoring their blood glucose levels, especially those with diabetes. These devices provide vital measurements to help manage health and prevent emergencies related to blood sugar levels.
The E-5 error code may indicate critical health issues, but the current labeling fails to instruct users to seek immediate medical attention. This could inadvertently lead users to neglect necessary healthcare responses when facing symptoms of high blood glucose.
This recall is not part of a broader industry pattern.
Users may face significant safety risks due to the potential for mismanagement of high blood glucose levels, leading to serious health complications.
Model numbers can typically be found on the device itself or within the user manual.
You can expect a refund or resolution within 4-6 weeks after submitting your request.
Keep detailed records of all communications regarding the recall, and photograph the device and any damage or issues as evidence.
Models affected include Walgreens TRUE METRIX Kit/RE4001-01, CVS TRUE METRIX Kit/RE4007-01SB, and others. Products were sold nationwide in the U.S. and in countries including Mexico, the United Kingdom, and Australia. The recall was issued on February 6, 2026.
No injuries or incidents have been reported.
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